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NCT02383589 · BASELINE

Baseline characteristics

A Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil (MMF) in Participants With Pemphigus Vulgaris (PV) · Source last updated 2020-11-10

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms
  1. counts
    1. group Id
      BG000
      value
      67
    2. group Id
      BG001
      value
      68
    3. group Id
      BG002
      value
      135
    units
    Participants
groups
  1. description
    Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants who withdrew from the treatment period or who completed the total 52-week treatment period entered the safety follow up (SFU) period, and they were observed for 1 year and did not receive any further study treatment.
    id
    BG000
    title
    Rituximab (RTX)
  2. description
    Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants who withdrew from the treatment period or who completed the total 52-week treatment period entered the safety follow up (SFU) period, and they were observed for 1 year and did not receive any further study treatment.
    id
    BG001
    title
    Mycophenolate Mofetil (MMF)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.98
          value
          50.66
        2. group Id
          BG001
          spread
          13.08
          value
          46.34
        3. group Id
          BG002
          spread
          13.16
          value
          48.48
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          73
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          62
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          34
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          86
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          13
        title
        Not Stated
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        Black or African American
      4. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          100
        title
        White
      5. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          27
        title
        Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      67
    2. group Id
      BG001
      value
      68
    3. group Id
      BG002
      value
      135
    units
    Participants
groups
  1. description
    Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants who withdrew from the treatment period or who completed the total 52-week treatment period entered the safety follow up (SFU) period, and they were observed for 1 year and did not receive any further study treatment.
    id
    BG000
    title
    Rituximab (RTX)
  2. description
    Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants who withdrew from the treatment period or who completed the total 52-week treatment period entered the safety follow up (SFU) period, and they were observed for 1 year and did not receive any further study treatment.
    id
    BG001
    title
    Mycophenolate Mofetil (MMF)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.98
          value
          50.66
        2. group Id
          BG001
          spread
          13.08
          value
          46.34
        3. group Id
          BG002
          spread
          13.16
          value
          48.48
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          73
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          62
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          34
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          86
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          13
        title
        Not Stated
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        Black or African American
      4. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          100
        title
        White
      5. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          27
        title
        Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice